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Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications (CaRISMA)

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ClinicalTrials.gov Identifier: NCT04419168
Recruitment Status : Not yet recruiting
First Posted : June 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Charles Jonassaint, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE May 28, 2020
First Posted Date  ICMJE June 5, 2020
Last Update Posted Date June 5, 2020
Estimated Study Start Date  ICMJE July 2020
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2020)
Change in Pain interference [ Time Frame: 3, 6, 12 months ]
- PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference Scale a validated questionnaire that assesses how day-to-day function is altered by pain. Range 8-40, higher scores may mean that pain limits your activity level and enjoyment of certain activities
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2020)
Change in Daily pain intensity [ Time Frame: 3, 6, 12 months ]
Daily pain intensity: 3, 6 and 12-month change in average daily pain intensity "Using any number from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable, what is your pain level today?"
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications
Official Title  ICMJE Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications
Brief Summary The investigators are conducting a comparative effectiveness trial among adult patients with sickle cell disease (SCD) who report chronic pain (N = 350), randomized to receive either mobile phone-delivered computerized cognitive behavioral therapy (cCBT; n = 175) or digital education (m-Education; n = 175). Both intervention groups will receive weekly (more frequent if requested or needed) follow-up with a health coach for at least 3 months to reinforce learned materials. Both groups will also use their mobile device to track daily pain, mood, and medication used for two-week periods at baseline and each of the follow-up points (3, 6 and 12 months). Participants will also be given access to a study-associated online support group page where members can discuss with other patients, issues participants faced and what skills were or could be used to address them. Participants will continue all routine care including opioid pain management and novel therapies.
Detailed Description

The study interventions are both Internet-delivered, evidence-based tools that have been tailored specifically for the target population through a user-centered approach that has engaged stakeholders at each stage of the process.

  1. Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.
  2. Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
comparative effectiveness trial
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Pain
  • Depression, Anxiety
  • Opioid Use
Intervention  ICMJE
  • Other: cCBT
    A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
  • Other: m-Education
    A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.
Study Arms  ICMJE
  • Experimental: cCBT
    Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.
    Intervention: Other: cCBT
  • Experimental: m-Education
    Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.
    Intervention: Other: m-Education
  • No Intervention: Convenience Comparison
    Not participating in the intervention. Participants will complete the baseline questionnaire battery only and we will abstract their medical record data for the 12-months before enrollment and 12-months post enrollment.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2020)
350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2024
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • People with any type of sickle cell disease
  • Male or female, age 18 years or older
  • Reports chronic pain: i.e pain more days that not for the past 3 months or longer and/or is prescribed daily or long-acting opioids for pain.
  • English speaking

Exclusion Criteria:

  • Any potential participants who fail consent comprehension questions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Charles Jonassaint, PhD 412-586-9850 cjonassaint@pitt.edu
Contact: Laura De Castro, MD 412-648-6575 decastrolm@upmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04419168
Other Study ID Numbers  ICMJE PRO20030015
CER-2018C2-13320 20 ( Other Grant/Funding Number: PCORI )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Charles Jonassaint, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Pittsburgh
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP